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experimental

Phase 2

Postmenopausal | Small molecule | Other |Sanofi|Last Updated: Apr 17, 2013

Development status

Highest phase Phase 2
Registered trials 13 across 13 sponsors since Jul 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment370

FDA Designations

No designations recorded

Clinical trial landscape

experimental · 1 trial · 1 indication

Phase 2 1
NCT00577837Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMDPostmenopausal
COMPLETED370 Analytics
PHASE2COMPLETED
Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
Postmenopausal
NCT00577837370
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Study Endpoints

Primary Endpoints

Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles
6 months

Secondary Endpoints

Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR5 mg risedronate, once daily for 6 months
2EXPERIMENTAL100 mg risedronate, once a month for 6 months
3EXPERIMENTAL150 mg risedronate, once a month for 6 months
4EXPERIMENTAL200 mg risedronate, once a month for 6 months

Interventions

NameTypeDescription
risedronateDRUGtablet, 5 mg risedronate daily for 6 months
experimentalDRUGtablet, 200 mg risedronate monthly for 6 months
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Eligibility Criteria

Age Range50 Years to 85 Years
SexFEMALE
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * be postmenopausal 5 years based on medical history; follicle stimulating hormone and estradiol will be evaluated for any patient less than 65 years of age, who has undergone hysterectomy without bilateral oophorectomy, to ensure the patient is postmenopausal Exclusion Criteri...

Countries:United StatesCanadaCroatiaNetherlandsPoland
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